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ISRCTN
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ISRCTN33909010
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ClinicalTrials.gov identifier
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NCT00615433
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Public title
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A phase 3 randomised placebo- and active comparator-controlled, clinical trial to study the safety and efficacy of two doses of lurasidone HCL in acutely psychotic patients with schizophrenia
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Scientific title
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Acronym
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N/A
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Serial number at source
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D1050231
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Study hypothesis
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Lurasidone HCl demonstrates greater efficiency, safety and tolerability in acutely psychotic patients with schizophrenia as compared with placebo.
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Ethics approval
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Ethics approval received from:
1. Bulgaria: Multicentre trials Ethics Committee (MEC) on the 29th April 2008
2. Colombia: Research Ethics Committee (Comite de Etica en Investigacion Servicios Psiquiatricos S.A.) on the 12th February 2008
3. Lithuania: Central EC, Lithuania Bioethics Committee on the 27th February 2008
4. Serbia: Ethics Committee of Clinical Centre of Serbia on the 12th February 2008
Ethics approval pending from:
5. India: Ethics Committee of the Hospital for Mental Health. Expected approval date: 30 April 08.
6. Peru: Research Ethics Committee (Comite de Etica en Investigacion Hospital Nacional Guillermo Almenara). Expected approval date: 20 April 08.
7. Philippines: National Ethics Committee/National Centre for Mental Health. Expected approval date: 29 June 08.
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Study design
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Randomised, double-blind parallel group study.
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Countries of recruitment
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Bulgaria, Colombia, India, Lithuania, Peru, Philippines and Serbia
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Disease/condition/study domain
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Schizophrenia
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Participants - inclusion criteria
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1. Aged between 18 and 75 years of age, both genders
2. Those who provide written informed consent
3. Meets Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV) criteria for a primary diagnosis of schizophrenia
4. Not pregnant; if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study
5. Able and agrees to remain off prior antipsychotic medication for the duration of study
6. Good physical health on the basis of medical history, physical examination, and laboratory screening
7. Willing and able to comply with the protocol, including the inpatient requirements and outpatient visits
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Participants - exclusion criteria
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1. Considered by the investigator to be at imminent risk of suicide or injury to self, others or property
2. Any chronic organic disease of the central nervous system (CNS) (other than schizophrenia)
3. Used investigational compound within 30 days
4. Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months
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Anticipated start date
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01/01/2008
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Anticipated end date
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30/10/2009
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Status of trial
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Ongoing
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet.
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Target number of participants
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Approximately 480 patients
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Interventions
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There is a 14-day screening period and a 7-day placebo washout period before randomisation of the participants for the acute phase of the trial.
Acute phase:
Patients will be randomly assigned to one of the four treatment arms in equal numbers:
Arm 1: Lurasidone HCI 40 mg/day orally for 6 weeks
Arm 2: Lurasidone HCl 120 mg/day orally for 6 weeks
Arm 3: Olanzapine 15 mg (oral use film-coated tablet/capsule) for 6 weeks
Arm 4: Placebo for 6 weeks
Open label extension phase:
All participants who complete the 6-week acute phase will be given treatment with open label lurasidone HCl (oral) for 6 months.
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Primary outcome measure(s)
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Change in total PANSS (the Positive And Negative Syndrome Scale) score from baseline to the end of the 6-week double-bind treatment period.
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Secondary outcome measure(s)
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Clinical Global Impressions - Severity (CGI-S) from baseline to the end of the double-blind treatment.
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Sources of funding
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Dainippon Sumitomo Pharma Co., Ltd (Japan)
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Trial website
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Publications
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Contact name
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Ms
Shelda
Alcock
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Address
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Dainippon Sumitomo Pharma Europe Ltd
First Floor
Southside
97-105 Victoria Street
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City/town
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London
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Zip/Postcode
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SE1E 6QT
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Country
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United Kingdom
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Sponsor
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Dainippon Sumitomo Pharma America Inc. (USA)
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Address
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One Bridge Plaza
Suite 510
Fort Lee
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City/town
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New Jersey
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Zip/Postcode
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07024
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Country
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United States of America
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Date applied
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26/02/2008
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Last edited
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03/06/2008
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Date ISRCTN assigned
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21/04/2008
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